Finger or hand-operable actuators are typically adapted to be incorporated in dispensing devices or systems mounted to, housing, or operatively engaged with containers storing a fluent substance or product. Some actuators are designed for use with a device having a suitable discharge structure or nozzle to produce a substance having desired properties or a desired consistency (e.g., such as an atomized spray, a foam, cream, etc.).
A dispensing package comprising such a nozzle and cooperating actuator is typically used for dispensing or dosing one or more medicaments in spray form, such as a rapid onset sublingual fentanyl spray, as well as other personal care or industrial products. SUBSYS® (SUBSYS is a registered trademark of and available from Insys Development Company, Inc.) is a commercially available rapid onset sublingual fentanyl spray covered by U.S. Pat. Nos. 8,486,972; 8,486,973; 8,835,459; 8,835,460; 9,241,935 and 9,289,387. “Sublingual” means “under the tongue” and refers to administration of a substance via the mouth in such a way that the substance is rapidly absorbed via the blood vessels under the tongue.
The SUBSYS® fentanyl spray is provided within and by a unit-dose spray package manufactured by Aptar Pharma, a subsidiary of AptarGroup, Inc., having principal offices at 475 W. Terra Cotta Ave., Suite E, Crystal Lake, Ill. The unit-dose spray package has a generally T-shaped body containing a sealed chamber with a predetermined unit-dose of the fluid medicament. The body is provided with a movable plunger extending within and from the body, which is slidably received therein, and which is located in confronting relationship with the sealed chamber. The body has an internal passageway terminating in a spray or exit orifice in the form of a nozzle for generating the SUBSYS® fentanyl spray when the plunger is sufficiently forced into the body by a user of the package to breach the sealed chamber. One or more frangible tabs, seals, or membranes initially prevents movement of the plunger relative to the body until the user accumulates a predetermined force on the plunger sufficient to rupture the frangible tabs.
The inventors have found that some users of such a package who are in a weakened state (e.g., those users having arthritis, undergoing cancer treatment, or suffering from other ailments affecting strength or coordination) may encounter difficulty in actuating and obtaining a proper unit-dose from the package. Specifically, it has been found by the inventors that such users may be unable to properly actuate the package by moving the plunger into the T-shaped body. Failure to breach the sealed chamber containing the unit-dose of a medicament in a fluid stroke could result in the failure to generate any unit dose of SUBSYS® fentanyl spray, or a failure to generate the full dose of fentanyl spray.
The inventors have recognized a need for an improved actuator and method for such weakened or arthritic users for effectively dispensing a unit-dose of a medicament from a package.